Abbott Announces New Testosterone Test to Measure the ... | 合法醫療器材資訊網
2012年12月17日—PRESSRELEASES·IntendedUseTheARCHITECT2ndGenerationTestosteroneAssayisachemiluminescentmicroparticleimmunoassayfor ...
Published studies have shown, however, that many currently available testosterone tests are not sensitive enough to measure low levels of testosterone. This limits the clinical utility of these tests. To address this need and help physicians accurately measure the wide range of testosterone levels seen in men and women, Abbott announced today clearance from the U.S. Food and Drug Administration for a new testosterone test.
"The ARCHITECT 2nd Generation Testosterone Assay is more sensitive, accurate and precise than previous versions of the assay," said Frank Quinn, PhD, FACB, director of Global Scientific Affairs for Endocrinology, Abbott. "The improved assay performance means physicians will be able to obtain more reliable measurements of testosterone and use this information to help guide patient treatment decisions."
The new assay runs on Abbotts fully-automated ARCHITECT family...
Testosterone | 合法醫療器材資訊網
k120009 B. Purpose for Sub | 合法醫療器材資訊網
REVIEW MEMORANDUM | 合法醫療器材資訊網
Evaluation of Architect 2nd Generation Testosterone Assay ... | 合法醫療器材資訊網
SEP 2 .9 2004 ?.iitIb | 合法醫療器材資訊網
Potential interference in the Abbott Architect 2nd ... | 合法醫療器材資訊網
Abbott Announces New Testosterone Test to Measure the ... | 合法醫療器材資訊網
Potential interference in the Abbott Architect 2nd generation ... | 合法醫療器材資訊網
Data to support a simultaneous testosterone and estradiol ... | 合法醫療器材資訊網
【亞培設計師睪丸脂酮試劑組】許可證字號:衛署醫器輸字第015634號
器材品名:亞培設計師睪丸脂酮試劑組許可證字號:衛署醫器輸字第015634號註銷狀態:註銷日期:註銷理由:有效日期:2025/12/16發證...
【亞培愛可信睪丸脂酮試劑組】許可證字號:衛署醫器輸字第015035號
器材品名:亞培愛可信睪丸脂酮試劑組許可證字號:衛署醫器輸字第015035號註銷狀態:已註銷註銷日期:2018/08/09註銷理由:未展延...
【亞培設計師黃體生成素檢驗試劑組(未滅菌)】許可證字號:衛部醫器輸壹字第019902號
器材品名:亞培設計師黃體生成素檢驗試劑組(未滅菌)許可證字號:衛部醫器輸壹字第019902號註銷狀態:註銷日期:註銷理由:有效日...